Evoke® Closed-Loop Stimulator (CLS) 3042 (UDI 09352307001572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 322 adverse event reports that list this exact device (DI 09352307001572), received between Jul 8, 2024 and Sep 30, 2026 — classified as 322 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (71 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 322 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Communication or Transmission Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported difficulty establishing connection between the Evoke Closed Loop Stimulator (CLS) and Evoke Charger, resulting in the inability to perform a soft reset and charge the CLS. Troubleshooting was performed, and an attempt to connect the Evoke CLS to the Evoke Clinical Interface was unsuccessful. The patient was without therapy. A revision procedure was performed, and the CLS was replaced to resolve the reported event.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50945605 ↗
• InjurySep 30, 2026Communication or Transmission Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported difficulty establishing connection between the Evoke Closed Loop Stimulator (CLS) and Evoke Charger, resulting in the inability to perform a soft reset and charge the CLS. Troubleshooting was performed, and an attempt to connect the Evoke CLS to the Evoke Clinical Interface was unsuccessful. The patient was without therapy. A revision procedure was performed, and the CLS was replaced to resolve the reported event.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50945596 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported undesirable increase in stimulation while programming the Evoke Closed Loop Stimulator (CLS). The reported undesirable increase in stimulation occurred 2 weeks following a separate procedure in which electrocautery was used. It was suspected that the Evoke CLS may have been damaged due to electrocautery usage during the previous procedure. An explant procedure was performed to resolve the reported event.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50935547 ↗
• InjurySep 29, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50935546 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for wound dehiscence at the Evoke Closed Loop Stimulator (CLS) implant site. The patient did not report pain; however, the physician elected to explant the Evoke SCS System. The physician plans to re-implant the patient in three months. The Evoke SCS System was functioning as intended prior to the explant.

  Patient problems: Wound Dehiscence

  MAUDE report 50855679 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for wound dehiscence at the Evoke Closed Loop Stimulator (CLS) implant site. The patient did not report pain; however, the physician elected to explant the Evoke SCS System. The physician plans to re-implant the patient in three months. The Evoke SCS System was functioning as intended prior to the explant.

  Patient problems: Wound Dehiscence

  MAUDE report 50855678 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated in the emergency room for a possible infection. The physician¿s evaluation confirmed the patient had an idiopathic infection. The Evoke SCS System was explanted and medication was administered to resolve the reported event. The Evoke SCS System was confirmed to be functioning as intended prior to the explant.

  Patient problems: Unspecified Infection

  MAUDE report 50842693 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated in the emergency room for a possible infection. The physician¿s evaluation confirmed the patient had an idiopathic infection. The Evoke SCS System was explanted and medication was administered to resolve the reported event. The Evoke SCS System was confirmed to be functioning as intended prior to the explant.

  Patient problems: Unspecified Infection

  MAUDE report 50842690 ↗
• InjurySep 21, 2026Patient Device Interaction Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System requested a system explant due to inadequate pain relief and disliking the stimulation sensation. The patient additionally reported that they were experiencing phantom leg pain and the pain would increase during stimulation. During the patient¿s trial period and following the permanent implantation, the patient reported that adequate pain relief was achieved. The Evoke SCS System was explanted to resolve the reported event.

  Patient problems: Pain

  MAUDE report 50842412 ↗
• InjurySep 21, 2026Patient Device Interaction Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System requested a system explant due to inadequate pain relief and disliking the stimulation sensation. The patient additionally reported that they were experiencing phantom leg pain and the pain would increase during stimulation. During the patient¿s trial period and following the permanent implantation, the patient reported that adequate pain relief was achieved. The Evoke SCS System was explanted to resolve the reported event.

  Patient problems: Pain

  MAUDE report 50842410 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  Patient problems: Implant Pain

  MAUDE report 50811583 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  Patient problems: Implant Pain

  MAUDE report 50811582 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50807263 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for an infection at the Evoke Closed Loop Stimulator (CLS) implant site. The physician¿s opinion was that the Evoke SCS System did not cause or contribute to the infection. An explant procedure was performed, and medication was administered to resolve the reported event. The Evoke SCS System was confirmed to be functioning as intended prior to the explant.

  Patient problems: Unspecified Infection

  MAUDE report 50807259 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for a systolic blood pressure below 100. No signs or symptoms of an infection were identified during evaluation; however, the physician suspected a possible infection related to the Evoke SCS System. No additional intervention was performed due to absence of signs or symptoms of infection.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Infection

  MAUDE report 50753365 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for a systolic blood pressure below 100. No signs or symptoms of an infection were identified during evaluation; however, the physician suspected a possible infection related to the Evoke SCS System. No additional intervention was performed due to absence of signs or symptoms of infection.

  Patient problems: Low Blood Pressure/ Hypotension; Unspecified Infection

  MAUDE report 50753363 ↗
• InjurySep 9, 2026Patient-Device Incompatibility; Lack of Effect

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported pain at the Evoke Closed Loop Stimulator (CLS) implant site. The patient reported an unrelated trauma had occurred near the implant site, which may have contributed to the reported pain. Additionally, the patient reported inadequate pain relief since implantation. The Evoke SCS System was subsequently explanted. The Evoke SCS System was confirmed to be functioning as intended prior to the explant.

  Patient problems: Implant Pain; Inadequate Pain Relief

  MAUDE report 50690242 ↗
• InjuryAug 18, 2026Patient Device Interaction Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported a burning sensation in their left leg and subsequently switched off the Evoke SCS System. The patient continued to experience the burning sensation, to a lesser extent, the following day despite the Evoke SCS System remaining turned off. The patient¿s device was evaluated by a Saluda representative during a patient visit, and stimulation related anomalies were not identified. At the patient¿s request, the Evoke SCS System was explanted. The physician noted the patient suffers from increased anxiety and did not attribute the reported event to the Evoke SCS System.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50299930 ↗
• InjuryAug 18, 2026Patient Device Interaction Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported a burning sensation in their left leg and subsequently switched off the Evoke SCS System. The patient continued to experience the burning sensation, to a lesser extent, the following day despite the Evoke SCS System remaining turned off. The patient¿s device was evaluated by a Saluda representative during a patient visit, and stimulation related anomalies were not identified. At the patient¿s request, the Evoke SCS System was explanted. The physician noted the patient suffers from increased anxiety and did not attribute the reported event to the Evoke SCS System.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50299929 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was hospitalized due to an infection at the Evoke Closed Loop Stimulator (CLS) implant site. A washout procedure was performed and intravenous antibiotics were administered.

  Patient problems: Unspecified Infection

  MAUDE report 50276783 ↗
• InjuryAug 17, 2026Patient-Device Incompatibility

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported pain at the Evoke Closed Loop Stimulator (CLS) implant site when leaning back. A revision procedure was performed to reposition the CLS and resolve the reported event.

  Patient problems: Implant Pain

  MAUDE report 50276054 ↗
• InjuryAug 14, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported undesirable increase in stimulation following an abdominal surgery. Electrocautery use was reported during the procedure. During an impedance check, the patient reported unintended occurrence of stimulation. Increased artifacts were observed, and difficulty obtaining ECAP was noted during the reprogramming attempt. These observations did not exist during visits prior to the abdominal surgery. A revision procedure was performed and the Evoke Closed Loop Stimulator (CLS) was replaced.

  Patient problems: Inadequate Pain Relief; Undesired Nerve Stimulation

  MAUDE report 50252185 ↗
• InjuryJul 28, 2026Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported unintended stimulation while charging their Evoke Closed Loop Stimulator (CLS). The symptoms persisted during an impedance check and resulted in discomfort in the patient¿s abdominal region. Difficulties were encountered while attempting to download the device logs. The CLS was subsequently turned off. A revision procedure was performed, and the CLS was replaced to resolve the reported event.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 50063695 ↗
• InjuryJul 28, 2026Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported unintended stimulation while charging their Evoke Closed Loop Stimulator (CLS). The symptoms persisted during an impedance check and resulted in discomfort in the patient¿s abdominal region. Difficulties were encountered while attempting to download the device logs. The CLS was subsequently turned off. A revision procedure was performed, and the CLS was replaced to resolve the reported event.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 50063580 ↗
• InjuryJul 17, 2026Patient Device Interaction Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED THERE WERE NO IMPROVEMENTS OF THEIR ORIGINALLY INDICATED PAIN. THE EVOKE SYSTEM WAS CONFIRMED TO BE FUNCTIONING PROPERLY AND THE PATIENT HAD GOOD DERMATOME COVERAGE. HOWEVER, THE PATIENT DID NOT LIKE PARESTHESIA AND REQUESTED THE SYSTEM BE EXPLANTED. THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25861621 ↗